A Feasibility Study on Prediction of an ICD Shock by ICD-derived Data (PREDICT-ICDS)

September 3, 2015 updated by: Ngai Yin Chan, Princess Margaret Hospital, Hong Kong

PREDICTion of Implantable-Cardioverter Defibrillator Shock Study

The primary hypothesis is that an ICD shock may be predicted days in advance by a combined score derived from different data obtainable from the ICD

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Hong Kong, China, 999077
        • Recruiting
        • Princess Margaret Hospital
        • Contact:
        • Principal Investigator:
          • Ngai Yin Chan, MBBS

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

ICD recipients with documented cardiac arrest, ventricular tachycardia or ventricular fibrillation

Description

Inclusion Criteria:

  1. Age ≧ 18 and ≦ 80
  2. Patients have documented spontaneous and sustained ventricular arrhythmias in the last six months prior to the enrollment
  3. Patients who are in sinus rhythm, have dual-chamber ICD or CRT-D implanted at least one month before enrollment
  4. Patients who are in atrial fibrillation, have single-chamber ICD or CRT-D implanted at least one month before enrollment
  5. Patients who are compliant to CareLink follow-up

Exclusion Criteria:

  1. Patients who are pregnant
  2. Patients who are incapable of giving consent to the study
  3. Patients who have a life-expectancy of less than 2 years

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
ICD recipients
ICD recipients with documented cardiac arrest or ventricular arrhythmias
Device: ICD

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
ICD-derived T-wave alternans amplitude before ICD shock
Time Frame: 6 months
The T-wave alternans amplitude before an ICD shock will be measured in mV and compared to the baseline T-wave alternans amplitude
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Princess Margaret Hospital, Hong Kong

Investigators

  • Principal Investigator: Ngai Yin Chan, MBBS, Princess Margaret Hospital, Canada

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2013

Primary Completion (Anticipated)

January 1, 2016

Study Completion (Anticipated)

January 1, 2016

Study Registration Dates

First Submitted

March 24, 2013

First Submitted That Met QC Criteria

March 27, 2013

First Posted (Estimate)

April 2, 2013

Study Record Updates

Last Update Posted (Estimate)

September 4, 2015

Last Update Submitted That Met QC Criteria

September 3, 2015

Last Verified

September 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PREDICTICDS01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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